Kornimate/medical-research-clean huggingface dataset:
pain and comfort in diabetic foot ulcer care

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to reveal the effect of cold application of 0.9% nacl solution used during diabetic foot ulcer (dfu) care on the pain and comfort levels of patients. in this direction; - cold application has no effect on pain and comfort levels in dfu care. - cold application has an effect on pain and comfort levels in dfu care. hypotheses were created. in order to reveal the effect of cold application, 0.9% nacl was compared to the intervention group (+4ͦ c and +8ͦ c); nacl ( sodium chloride) compared to the control group (+18ͦ c and +24ͦ c).

diabetic foot ulcer (dfu) prevalence is increasing in parallel with the increasing number of patients with diabetes mellitus (dm). patients experience pain due to debridement, which is frequently used in dfu care. therefore, it is seen that nonpharmacological strategies are needed in pain management, unlike pharmacological methods. for this purpose, this single-blind randomized controlled study attempted to provide more information to the literature for supportive care in dfu care. 68 dfu patients were included in the study. after being randomly assigned to the groups, the care solution was applied cold or hot according to the procedure in the dfu care performed in the outpatient clinic. data were collected before (10 min before), during and after (10 min after) the procedure. kruskal wallis, one way anova, post hoc pairwise comparison tests and corrected bonferroni were used in the analyses.

Eligibility criteria:
inclusion criteria: * patients over the age of 18 with a diabetic foot wound diagnosed with diabetes mellitus, * no cognitive impairment, * no hearing, understanding or speaking problems, * vas\>3 points, * patients who consent to participate in the study exclusion criteria: * patients who have been decided to have an intervention to reduce pain before the procedure (such as local anesthesia, nerve blockade, opioid analgesics, etc.) -patients with vas \<3 points, * patients with arterial or venous ulcers other than dfu

Keywords: diabetic foot ulser pain cold application comfort
a trial to compare three methods of performing hysterosalpingography

Conditions: Infertility

Summary: the purpose of this study is: * to determine whether the choice of the device for performing hysterosalpingography on the basis of the cervix characteristics can reduce the procedure failure rate; * to determine whether patient medical history is correlated with the degree of pain experienced during the hsg procedure.

a group of women will be randomized to undergo hsg, using 1) a balloon catheter in a first group of patients; 2) a cervical vacuum cup in a second group; 3) one of the two devices decided by the operator depending on the cervix characteristics in a third group (that will be named "operator's choice"). the operator will ask the woman to evaluate the degree of pain experienced during the application of the device and the injection of the contrast, after 2, 6 and 24 hours. the degree of pain will be evaluated using the vas system, an analogue scale rating from 1 to 10. a nurse will notice the patient's reaction and will evaluate the pain, depending on the movements of the hands and the body and the woman's moaning. moreover, the assistant will note down the personal data and the history of the patient. the operator will record the objective and subjective difficulty of the performance, using a rating scale from 0 to 9. the length of the procedure, the volume of contrast used, the amount of radiations and the time of exposure of the patient will also be considered. at the end of hsg both the gynaecologist and the radiologist will express their satisfaction upon the examination with a score from 0 to 10.

Eligibility criteria:
inclusion criteria: * infertility exclusion criteria: * hypersensitivity to iodine or radio-opaque contrast dye * cervicitis * genital bleeding * genital malignancy

Keywords: balloon catheter cervical vacuum cup hysterosalpingography infertility pain fallopian tube patency tests female infertility
glutamine enriched total parenteral feeding and proline metabolism in severely burned patients

Conditions: Burns

Summary: proline is a non-essential amino acid that helps with collagen formation. collagen is one of the main ingredients of skin, bone, tendons, and connective tissue. it is thought that proline becomes depleted in burn patients because it is being used in greater than normal quantities to help the injured skin and connective tissue heal. if this is true, then the body must look for alternate energy sources as proline becomes depleted. this study aims to evaluate 1)the metabolic kinetics of the amino acids proline, glutamate, and ornithine and 2) the effects of glutamine supplemented total parenteral nutrition (tpn) on the metabolism of these amino acids.

proline is a nutritionally dispensable (non-essential) amino acid. its synthesis and catabolism is via the pathway of ornithine and glutamate. the latter two amino acids serve as immediate precursors for proline, as well as metabolites. ornithine is one of the intermediates for urea cycle. glutamate is metabolically connected to tricarboxylic acid (tca) cycle, the major cycle for energy production. it is hypothesized that the significantly increased rates of net nitrogen loss and energy "production", as the consequence of the accelerated activities of both the urea and tca cycles in burn injury "drain" both ornithine and glutamate, thus depleting tissues of the availability of proline. hence, the de novo synthesis of proline is likely to be affected by the reduced availability of its major precursors: glutamate and ornithine. we further propose that increased supply of glutamine would increase the de novo synthesis of proline and / or spare the loss of proline via its metabolite glutamate. hence, glutamine will be beneficial to the overall nutritional status of the burn patients.

Eligibility criteria:
inclusion criteria: burn patients being treated at mgh burn unit with one or more of the following criteria: 1) \>=5% tbsa; 2) inhalation injury; or 3) resting energy expenditure (ree) of \>15% of the predicted basal metabolic rate using the harris-benedict equation. must be receiving total parenteral nutrition in the course of their treatment. exclusion criteria: patients with thyroid disease. patients who are not hemodynamically stable or show unstable vital signs patients at the stage of major organ failure, e.g. renal and/or liver failure.

Keywords: parenteral nutrition burn injury stable isotopes proline metabolic kinetics ornithine metabolic kinetics glutamate metabolic kinetics glutamine metabolic kinetics
baduanjin lower elevated blood pressure study

Conditions: Elevated Blood Pressure

Summary: the aim of this study is to evaluate the effects of baduanjin on blood pressure in individuals with high normal blood pressure (sbp 130-139 mmhg, and/or dbp 85-89 mmhg), as well as on glucose and lipid metabolism, quality of life, psychology, exercise, immune inflammation, endothelial function, and arterial stiffness.


Eligibility criteria:
inclusion criteria: * age 40 years or older; * systolic blood pressure (sbp) \<140 mmhg and diastolic blood pressure (dbp) \<90 mmhg * sbp 130-139 mmhg, and/or dbp 85-89 mmhg exclusion criteria: * diagnosis of hypertension (sbp≥140 mmhg, and/or dbp ≥90mmhg） * history of cardiovascular diseases, such as coronary heart disease, heart failure, stroke, and peripheral vascular disease * diagnosis of chronic kidney disease, primary aldosteronism, cushing's syndrome, or pheochromocytoma * newly diagnosed cancer or cancer metastasis within 5 years * history of autoimmune disease * having taken antihypertensive drugs or immunoregulators within 2 weeks * a long-term need for antihypertensive drugs or immunomoregulators * unable to maintain moderate intensity exercise due to illness or other reasons * pregnant, breastfeeding, or planning to become pregnant within the next 1 year * currently taking regular exercise (at least 30 minutes of moderate-intensity exercise at least three times a week) * allergic to sports bracelets * having participated or been participating in other clinical trials within the last 3 months * unable to use smartphones * other factors that may affect the follow-up, such as alcohol or substance abuse in the last 12 months, planing to live out of town for a long time, or diagnosis of dementia or cognitive impairment which indicates incapability of completing the study * unable to accurately measure blood pressure using the sphygmomanometer provided by the study due to a too large or too small arm circumference

Keywords: baduanjin elevated blood pressure antihypertensive effect randomized controlled trial
a phase i, first in human study of cba-1205, anti-dlk1 monoclonal antibody in patients with advanced solid tumors and hepatocellular carcinoma (hcc)

Conditions: Hepatocellular Carcinoma (HCC); Solid Tumors

Summary: in this first-in-human, multicenter,non-randomized, open-label, standard 3+3 dose escalation phase i study encompasses 3parts(part1-3). the purpose of this fih study is to evaluate the safety and tolerability profile of cba-1205.

to evaluate safety and efficacy of cba-1205 in the following three parts in a stepwise manner: * in part 1, safety and tolerability in patients with solid tumor where no standard treatment is available, or who are intolerable or non-responder to the standard treatment will be evaluated. initial dose for part 2 will be determined. * in part 2, safety and tolerability in patients with advanced and/or recurrent hepatocellular carcinoma which are unresectable, or who are intolerable or non-responder to the standard treatment will be evaluated. recommended dose in this population will be determined. * in part 3, safety and efficacy at the recommended dose in patients with advanced and/or recurrent hepatocellular carcinoma which are unresectable, or who are intolerable or non-responder to the standard treatment will be evaluated. * pk analysis

Eligibility criteria:
inclusion criteria: * patients who provide voluntary written informed consent to participate in the study * patients with an eastern cooperative oncology group (ecog) performance status (ps) of≤1 * patients with preserved renal function as evidenced by laboratory data obtained within 7 days before enrollment (creatinine: ≤ uln ×1.5) * patients who meet the following laboratory criteria of bone marrow function as evidenced by laboratory data obtained within 7 days before enrollment: neutrophil count;≥1500/μl, platelet count; ≥75000/μl, hemoglobin;≥9.0 g/dl. * patients having solid tumors with no standard therapy available or refractory or intolerable to standard therapy * patients with unresectable advanced/recurrent hepatocellular carcinoma refractory or intolerable to standard therapy (part2, 3: hcc) * patients with child-pugh a or b (part2, 3; hcc) exclusion criteria: * patients who have undergone major surgery within 28 days before enrollment * patients who have received anticancer treatment with surgical therapy, radiation therapy, and/or drug therapy within 14 days before enrollment * patients who have received anticancer treatment with immune checkpoint inhibitor, etc. within 28 days before enrollment * patients with grade 2 or higher concurrent disease or prior therapy-related toxicity * patients who have received any other investigational product within 28 days before enrollment * patients with current or previous inadequately controlled or clinically significant cardiac disease * patients who, in the opinion of the investigator or subinvestigator, is not appropriate

Keywords: dlk1 first in human phase i antibody solid tumor hepatocellular carcinoma cba-1205
the chinese hypertrophic cardiomyopathy study(chcs)

Conditions: Cardiomyopathy, Hypertrophic

Summary: hypertrophic cardiomyopathy (hcm) is one of the most common inherited cardiac diseases, with a prevalence of ∼0.2%. sudden cardiac death (scd), heart failure and stroke are the major poor outcomes of hcm. although about half of the patients were found to be caused by mutations mainly located in genes encoding sarcomere proteins, the causes in a significant proportion of patients with hcm are still unknown. even in the patients with sarcomere mutations, the molecular pathways that eventually lead to cardiac hypertrophy are remained to be revealed. furthermore, hcm presents with significant heterogeneity. scd risk stratification and prevention by icd are necessary. however, the strategy of scd risk stratification recommended by the 2011 accf/aha and 2014 esc guidelines were based mainly on the evidence derived from american and european countries. the accuracy of these guidelines in chines patients with hcm was not evaluated yet.

in the present study, patients with hcm are recruited prospectively after informed consent was given. the investigator will collect the baseline clinical characteristics of the patients at enrollment, including comprehensive physical examination, laboratory testing of blood and urine, electrocardiography, 24-hr holter, echocardiography, mri and other examinations if necessary. the specimens retained include blood for all patients and myocardium for patients receive surgery of myocardial myectomy. multi-omics screening, including genomics, epigenomics, transcriptomics, proteomics, metabolomics, will be performed to identified novel disease genes, signal pathway or processes, genetic risk factors and potential therapy targets of hcm. furthermore, besides examining the accuracy of scd risk prediction of the 2011 accf/aha and 2014 esc guidelines, we will identify novel risk factors associated with the clinical outcomes and construct predictive models suitable for chinese patients with hcm.

Eligibility criteria:
inclusion criteria: patients with hcm diagnosed by observation of unexplained maximal left ventricle wall thickness ≥15 mm on echocardiography and/or cardiac magnetic resonance imaging or or ≥13 mm for individuals with family history of hcm. exclusion criteria: individuals with other cardiac or systemic diseases capable of producing that magnitude of cardiac hypertrophy.

Keywords: hypertrophic cardiomyopathy clinical outcomes multi-omics risk stratification
exercise and vascular function in chronic kidney disease

Conditions: Chronic Renal Insufficiency

Summary: the purpose of this study is to investigate the effects of 12 weeks of aerobic exercise training on blood vessel function in stages 1-4 chronic kidney disease.

the endothelium lines the inside of the blood vessels. a healthy endothelial lining acts as a defense mechanism against vascular injury, mediating vascular tone, vascular structure, and blood-vessel wall relations. endothelial dysfunction marks the occurrence of cardiovascular injuries and is a critical step in the development of cardiovascular disease. individuals with chronic kidney disease (ckd) have an increased risk of cardiovascular disease and this may be related to poor blood vessel function. interventions to improve blood vessel function in ckd are needed. exercise training has been shown to improve blood vessel function in older subjects and those with heart disease but this has not been investigated in ckd. the national kidney foundation recommends exercise for dialysis patients to reduce cardiovascular risk however there is very little data regarding the benefits of exercise in earlier stages of ckd. the purpose of this study is to determine the effect of 12 weeks of exercise training on blood vessel function in moderate to severe ckd.

Eligibility criteria:
inclusion criteria: * ckd exercise and ckd control arms: stage 1 - 4 chronic kidney disease (egfr 15 - 90 ml/min/1.73m2) * healthy control arm: egfr \> 90 ml/min/1.73m2) exclusion criteria: * history of cardiovascular disease * uncontrolled hypertension * lung disease * liver disease * cancer * immunosuppressant or antiretroviral therapy * current tobacco use * pregnancy * hormone replacement therapy * unable to give consent

Keywords: exercise therapy endothelium, vascular blood vessels
evaluation of response to a course of repetitive transcranial magnetic stimulation using vocal biomarkers

Conditions: Major Depressive Disorder

Summary: voice recordings taken prior to the start of repetitive transcranial magnetic stimulation (rtms) therapy will be used to develop a predictive model of treatment response using machine learning for patients with major depressive disorders (mdd).

the objective of this study is to investigate whether voice biomarkers taken prior to the start of rtms can predict the response to a 30-session course of rtms in patients with mdd with good sensitivity and specificity. patients who are prescribed rtms to treat an episode of mdd at one of the nine participating centres will be invited to participate in the study. the protocol includes one inclusion visit and seven evaluation visits before, during, and after the course of rtms. the rtms course will last for six weeks, comprising of 30 sessions with five sessions per week. prior to the commencement of the rtms course, patients will need to complete several questionnaires. before the first session, voice tests will be recorded using the callyope application. patients will answer questionnaires and assess voice tests weekly and after the final rtms session to track the progression of depressive symptoms.

Eligibility criteria:
inclusion criteria: * having a prescription for a course of rtms to treat an episod of mdd * unipolar mdd confirmed according to dsm-5 criteria * moderate to severe mdd (madrs score \> 19) * no use of psychotropic medication or use stabilised (no change in dose \< 4 weeks before study entry) * able to understand, speak, read and write french * express informed consent, after a period of reflection * affiliated with a french social security scheme or beneficiary of such a scheme exclusion criteria: * history of epilepsy or convulsive seizures * previous brain surgery * history of recent cranial trauma (\< 6 months) * presence of severe suicidal ideation * psychotic disorders * metal objects in the head, eyes or brain * implanted ferromagnetic equipment (pace maker, cochlear implant, etc.) * clinical evidence of serious or uncontrolled alcohol or substance use disorders in the three months prior to the study * active withdrawal from alcohol or other substances * one or more recent rtms sessions (\< 4 weeks) * other non-drug therapy recently initiated (\< 4 weeks) to treat edc (psychotherapy, phototherapy, vagus nerve stimulation, etc.) * pathology altering phonation based on the perception of the investigator * subjects in a period of relative exclusion from another protocol * adults protected by law or patients under guardianship or curatorship * subjects deprived of their liberty by judicial or administrative decision * pregnant or breast-feeding women
programmed intermittent epidural bolus for laboring obstetrical women

Conditions: Labor Pain

Summary: comparison of three programmed intermittent epidural bolus (pieb) pump settings for maintenance of labour analgesia.

the optimal pieb and patient controlled epidural administered (pcea) bolus settings are still unknown. therefore, in this study, the investigators aim to compare analgesia outcomes both high and low pieb flow rate settings.

Eligibility criteria:
inclusion criteria: * singleton, vertex presentations at term (37-42 weeks gestational age) * \</= 5cm cervical dilation at the time of epidural anesthesia request * asa 2-3 patients aged 19 or over who are able to provide informed consent exclusion criteria: * contraindications to neuraxial analgesia or risk factors likely to affect placement or function of the epidural * history of hypersensitivity or idiosyncratic reaction to local anesthetics or opioids * current or historical evidence of any significant medical conditions * clinical settings in which continuous epidural infusion may be preferable * risk factors significantly increasing the need for cesarean delivery * anticipated fetal abnormalities

Keywords: labor analgesia programmed intermittent epidural bolus
study with docetaxel, carboplatin and herceptin versus vinorelbine and herceptin in her-2 (+) metastatic breast cancer patients

Conditions: Breast Cancer

Summary: this trial will compare the efficacy of sequential administration of docetaxel, carboplatin and herceptin versus the administration of vinorelbine and herceptin combination as first line treatment in her-2 positive patients with metastatic breast cancer.

herceptin, a humanized monoclonal antibody directed against the extracellular domain of the transmembrane glycoprotein her2/neu (c-erbb-2), is a valuable option in the treatment of women with her2-positive metastatic breast cancer. the combination of herceptin and chemotherapy yielded significantly better results than chemotherapy alone in response, time to progression, and survival time. whether the combination of docetaxel, carboplatin and herceptin versus the administration of vinorelbine and herceptin combination in her-2 positive patients with metastatic breast cancer is preferable is not yet known.

Eligibility criteria:
inclusion criteria: * performance status (who) 0-2 * histologically confirmed metastatic breast adenocarcinoma (stage iv) without any prior chemotherapy received * her-2 overexpression 2+ or 3+ using ihc or fish + * measurable disease not in a prior irradiation field (no other concurrent chemotherapy agents) * no more than 25% of myeloproductive bone marrow irradiated (more than 4 weeks since prior radiotherapy and recovered) * more than 6 months since prior adjuvant or neoadjuvant chemotherapy and recovered * no prior first line chemotherapy for metastatic disease * endocrine therapy is allowed as adjuvant or first line treatment for metastatic disease * paraffin block from the primary tumor available in the research lab * adequate bone marrow function (absolute neutrophil count \> 1000/mm\^3, platelet count \> 100000/mm\^3, hemoglobin \> 9 gr/mm\^3) * adequate liver (bilirubin \< 1.5 times upper limit of normal and sgot/sgpt \< 2 times upper limit of normal) and renal function (creatinine \< 2mg/dl) * adequate cardiac function (lvef \> 50%) * informed consent exclusion criteria: * pregnant or nursing * concurrent agents ketoconazole, macrolide antibiotics, zidovudine which may induce p-450 cytochrome * positive pregnancy test * motor or sensory neuropathy \> grade 1 according to ncic τoxicity criteria * patients with brain metastatic disease who has not been irradiated or uncontrolled brain metastatic disease after irradiation * history of allergic reaction attributed to docetaxel * psychiatric illness or social situation that would preclude study compliance * other concurrent uncontrolled illness. * other invasive malignancy within the past 5 years except cured basal cell skin carcinoma and cervical carcinoma in situ

Keywords: cancer breast cancer first line treatment docetaxel carboplatin herceptin vinorelbine
lidocaine in-situ gel before intrauterine device insertion

Conditions: Pain Relief

Summary: intrauterine device can cause pain and discomfort in several ways: use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the insertion tube, and removing the tube; and placement of the device in the uterus.


Eligibility criteria:
inclusion criteria: * women not taken analgesics or anxiolytics in the 24 hours prior insertion * women not taken misoprostol prior to insertion * no contraindication to or history of allergic reaction to lidocaine * women who will accept to participate in the study exclusion criteria: * lidocaine allergy * any contraindication to device placement